Agreement on the Application of Sanitary and Phytosanitary Measures

The Agreement on the Application of Sanitary and Phytosanitary Measures, commonly known as the SPS Agreement, is a core WTO treaty governing the adoption and implementation of health-related trade measures. Concluded during the Uruguay Round of GATT negotiations and entering into force in 1995 with the establishment of the WTO, it sets rules for how countries may introduce regulations to protect human, animal, and plant life or health without unnecessarily restricting international trade. The agreement seeks to balance sovereign regulatory authority with the prevention of protectionist abuses in areas such as food safety, animal health, and plant protection.
The SPS Agreement is closely linked to the Agreement on Technical Barriers to Trade (TBT), but the two regulate different types of measures. Whereas the TBT Agreement concerns technical regulations and standards more broadly, SPS measures are confined to health-related risks associated with food, animals, and plants. This dedicated framework emerged from the recognition that cross-national differences in sanitary and phytosanitary rules were creating significant non-tariff barriers to trade—barriers not adequately addressed by earlier GATT rules.

Historical Background and Framework

Although the GATT primarily addressed tariff barriers, the growing prominence of non-tariff barriers prompted the need for a more comprehensive agreement. Countries had increasingly adopted divergent food safety and quarantine measures, often justified on public health grounds but with adverse effects on trade. The SPS Agreement was designed to address these disparities by requiring scientific justification for measures while preserving governments’ ability to respond to legitimate health risks.
The agreement also introduced an institutionalised approach to international standard setting by recognising three global standard-setting organisations:

• Codex Alimentarius Commission (food safety standards)
• World Organisation for Animal Health (OIE) (animal health)
• International Plant Protection Convention (IPPC) (plant health and phytosanitation)

Members are encouraged to base their SPS measures on the standards, guidelines, and recommendations of these bodies to promote harmonisation and reduce unnecessary variation in national regulations.

Main Provisions of the Agreement

General Provisions (Article 1 and Annex A)

The agreement applies to all SPS measures that directly or indirectly affect international trade. SPS measures are defined to include regulations intended to protect humans from food-borne risks, animals from diseases, and plants from pests, among other concerns. The definitions in Annex A categorise different forms of SPS interventions, such as quarantine procedures, residue limits, and food inspection rules.

Basic Rights and Obligations (Article 2)

Article 2 establishes the fundamental obligation that SPS measures must be based on scientific principles and must not be maintained without sufficient scientific evidence. Members may set their own desired level of protection, but their measures must not discriminate arbitrarily between countries with similar conditions. Additionally, SPS measures must not represent disguised restrictions on international trade.

Harmonisation (Article 3)

Article 3 encourages members to align their SPS measures with international standards. Where measures conform to Codex, OIE, or IPPC standards, they are presumed to be consistent with the SPS Agreement and GATT Article XX(b). However, Article 3.3 allows members to adopt higher levels of protection than international standards if they have a scientific justification or if a risk assessment supports the higher measure. This clause recognises national policy variation while ensuring transparency and scientific accountability.

Risk Assessment and Appropriate Level of Protection (Article 5)

Risk assessment is central to the SPS Agreement. Article 5 requires members to base SPS measures on an assessment of risks to human, animal, or plant health, taking into account methods developed by the relevant international organisations. Annex A.4 outlines the process of evaluating probability, biological effects, and potential harm.
Important elements include:

• Article 5.1: Measures must be grounded in risk assessment appropriate to the circumstances.
• Article 5.5: Members must avoid arbitrary distinctions in protection levels that could discriminate or restrict trade.
• Article 5.7: Allows provisional measures where scientific evidence is insufficient, reflecting the precautionary principle. Countries must seek further information and review such measures within a reasonable time.

Standard-Setting Organisations (Annex A.3)

The SPS Agreement formalises cooperation with the Codex Alimentarius Commission, OIE, and IPPC. These bodies serve as technical references for WTO adjudicators, particularly when determining whether national measures exceed what is scientifically justified.

Key WTO Disputes

Several major disputes have shaped the interpretation of the SPS Agreement.

EC – Hormones (Hormone-Treated Beef)

In this dispute, the United States and Canada challenged EU restrictions on hormone-treated beef. The EU justified its ban on public health grounds, but WTO panels found insufficient scientific evidence to support the measures. When the EU did not comply, the Dispute Settlement Body authorised the United States and Canada to impose retaliation. Subsequent EU appeals argued new scientific findings justified maintaining the ban, illustrating the difficulties in reconciling scientific uncertainty with trade obligations.

Japan – Agricultural Products

This case addressed Japan’s quarantine restrictions on various fruits and nuts. The Appellate Body clarified requirements relating to risk assessment and the need for scientific evidence. The ruling emphasised that SPS measures must closely correspond to outcomes of risk analysis and cannot rely on unverified assumptions.

Australia – Salmon

Australia’s import ban on salmon was found inconsistent with SPS obligations due to flaws in its risk assessment. The Appellate Body reaffirmed that risk assessments must be coherent, transparent, and grounded in recognised methodologies, not shaped by overly cautious or politically motivated judgments.

Japan – Apples

US apple producers challenged Japan’s phytosanitary restrictions aimed at preventing the introduction of fire blight. The WTO found Japan’s measures excessively restrictive relative to the assessed risk. The case highlighted the requirement to avoid arbitrary distinctions between different levels of protection.

EC – Biotech (GMOs)

In the biotech dispute, the United States, Canada, and Argentina challenged aspects of the EU’s regulatory procedures for genetically modified organisms. The panel criticised procedural delays but did not broadly invalidate the EU’s regulatory framework. The ruling clarified the boundary between SPS and TBT rules and highlighted the importance of scientific risk evaluation.

Interaction with Other WTO Instruments

Article 1.5 of the TBT Agreement excludes SPS measures from its scope. However, certain regulatory measures may contain both SPS and TBT components. In such cases, SPS-related aspects are evaluated under the SPS Agreement, while other elements fall under the TBT Agreement. Where a measure complies with SPS requirements, it is typically considered justified under GATT Article XX(b), which allows measures necessary to protect human, animal, or plant life or health.
This segmentation ensures that health-related measures are scrutinised under specialised criteria, while other technical regulations remain subject to broader trade disciplines.

Criticism and Controversies

Economic Implications

SPS measures can influence trade flows significantly. While they protect health and environmental interests, they may also function as barriers that restrict market access. Scholars note that economic considerations must not overshadow genuine health protections, particularly in cases where disruptions affect trade in high-value agricultural or food products.

Scientific Versus Legal Standards

Critics argue that WTO adjudication sometimes prioritises legal formalism over scientific complexity. Debates arise around the extent to which panels defer to national scientific assessments versus requiring strict methodological conformity with international bodies.

Precaution and Uncertainty

The SPS Agreement incorporates elements of the precautionary principle through Article 5.7, but its scope is contested. Some claim it restricts governments’ ability to act in the face of scientific uncertainty, while others argue it allows undue flexibility susceptible to abuse. The balance between precaution, science, and trade continues to provoke academic and policy debate.